Systems and methods for treating pulmonary hypertension

ABSTRACT

A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician&#39;s computer, a patient monitoring device, and a mobile application configured to run on a patient&#39;s mobile device.

I. CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent Ser. No. 14/531,846,filed Nov. 3, 2014, now U.S. Pat. No. 9,039,725, which is a continuationof U.S. Patent Serial No. 14/309,758, filed Jun. 19, 2014, now U.S. Pat.No. 8,876,850, the entire contents of each of which are incorporatedherein by reference.

II. FIELD OF THE INVENTION

This application generally relates to systems and methods for treatingpulmonary hypertension, including implantable devices for reducingpulsatile load in the pulmonary artery and external devices formonitoring the implantable devices.

III. BACKGROUND OF THE INVENTION

Pulmonary hypertension (PH) is defined as a rise in mean pressure in themain pulmonary artery. PH may arise from many different causes, but, inall patients, has been shown to increase mortality rate. A deadly formof PH arises in the very small branches of the pulmonary arteries and isknown as Pulmonary Arterial Hypertension (PAH). In PAH, the cells insidethe small arteries multiply due to injury or disease, decreasing thearea inside of the artery and thickening the arterial wall. As a result,these small pulmonary arteries narrow and stiffen, causing blood flow tobecome restricted and upstream pressures to rise. This increase inpressure in the main pulmonary artery is the common connection betweenall forms of PH regardless of underlying cause.

PH causes the larger pulmonary arteries to stretch and stiffen. As astroke volume of blood is delivered to the main pulmonary artery, theartery is already stretched and will not further expand. The lack ofexpansion causes a much larger rise in pressure with each heartbeat(called systolic or peak pressure) than would occur in a healthy,compliant vessel that could stretch to accommodate the stroke volume. Inbetween heart beats, the arteries in a diseased patient do not contractas they normally would and diastolic pressure and flow through the lungsdrops causing a reduction in cardiac output. The heart has to workharder to push the same stroke volume of blood into the stiff artery ata higher pressure. At the same time, the high pulse pressure travelsdown the pulmonary arteries to the small vessels and activates molecularsignaling pathways causing the cells to multiply more rapidly,accelerating disease progression.

As the pressure within the pulmonary artery increases, the right side ofthe heart enlarges and thickens to compensate, but eventually reachesthe point where it cannot continue to pump enough blood through thelungs to satisfy the body's need for oxygenated blood. This progressivereduction of blood flow is first noticed as shortness of breath whenexercising. Over time, the right ventricular remodeling worsens andpatients lose the ability to maintain a normal daily level of activityand enter end stage heart failure where the right ventricle dilates andloses effectiveness reducing blood flow even further. At the end stage,the patient mortality rate is high.

Current treatment protocols for PH and Primary PH include administrationof pharmaceuticals. However, such pharmaceuticals are extremelyexpensive and not sufficiently effective.

Previously known implantable systems having a balloon, conduit, andreservoir have been described. However, such systems suffer from anumber of drawbacks for use in treating pulmonary hypertension includingthe inability to effectively and efficiently monitor operation of thesystem after implantation.

It would therefore be desirable to provide systems and methods fortreating heart disease, such as pulmonary hypertension and right heartfailure, where the implantable components may be monitored externally.

IV. SUMMARY OF THE INVENTION

The present disclosure overcomes the drawbacks of previously-knownsystems by providing systems and methods for treating heart disease,e.g., pulmonary hypertension or right heart failure. The system includesan implantable component and external components for monitoring theimplantable component. The implantable component may include a compliantmember, e.g., balloon, coupled to a reservoir via a conduit. Preferably,the reservoir is adapted to be implanted subcutaneously and thecompliant member is adapted to be implanted in a pulmonary artery, e.g.,a diseased, enlarged, and stiff pulmonary artery. The externalcomponents may include a clinical controller component, monitoringsoftware configured to run a clinician's computer, a patient monitoringdevice, and a mobile application configured to run on a patient's mobiledevice.

The external clinical controller component may include a fluidicconnector configured to be coupled to the implantable component, e.g.,via the reservoir, to permit fluidic communication with the implantablecomponent. The fluidic connector may be a needle adapted to be insertedtranscutaneously into the implantable component, e.g., via insertion ofthe needle into a septum in the reservoir. In one embodiment, thefluidic connector is a conduit configured to be coupled to a partiallyimplanted conduit that is connected to the implantable component, e.g.,at the reservoir. The external clinical controller component also mayinclude one or more sensors, e.g., a pressure transducer, configured togenerate signals indicative of parameters, e.g., pressure, within theimplantable component. In one embodiment, a pressure transducer isconfigured to generate a signal indicative of pressure within thereservoir.

The monitoring software may be non-transitory computer readable mediaconfigured to run on a computer operatively coupled to the externalclinical controller. The non-transitory computer readable media may beconfigured to cause a graphical user interface to display informationindicative of the parameters, e.g., pressure, within the implantablecomponent based on the signals from the sensors.

The external monitoring component may be configured to wirelesslyactivate one or more sensors, e.g., a pressure sensor, disposed withinthe implantable component to cause the one or more sensors to sense aparameter, e.g., pressure, within the implantable component. Thesensor(s) may be configured to transmit a signal(s), e.g., pressuresignal, indicative of the sensed parameter to the external monitoringcomponent. The sensor(s) may be located in or on any part of theimplantable component.

The mobile application is configured to run on a mobile device, e.g.,smartphone, tablet, laptop, smart watch, or the like. The externalmonitoring component may be configured to transmit the signal to themobile device such that the mobile device may display informationindicative of the parameter sensed within the implantable componentbased on the signal. The mobile device may be configured to run aroutine to generate an alert if the sensed parameter is above a firstpredetermined threshold or below a second predetermined threshold.

The external clinical controller component may include a pressure sourceconfigured to hold fluid to be injected into the implantable componentthrough the fluidic connector when the fluidic connector is in fluidiccommunication with the implantable component. In addition, the externalclinical controller component may include a fluid movement mechanism,e.g., pump, plunger, configured to move fluid from the pressure sourcethrough the fluidic connector and/or to extract fluid from theimplantable component through the fluidic connector. The fluid in thepressure source may be pressurized. The fluidic connector lumen(s) mayinclude one or more valves and one or more sensors. The externalclinical controller component may have an actuator, e.g., button,trigger, actuation of which causes fluid to move from the pressuresource through the fluidic connector, e.g., by opening a valve.

The external clinical controller component may include one or moresensors configured to generate parameter signal(s) indicative of aparameter(s). Parameters may include pressure within the implantablecomponent, temperature within the implantable component, humidity withinthe implantable component, fluid flow rate within the implantablecomponent, volume of injected fluid from the external clinicalcontroller, volume of extracted fluid from the implantable component,CO₂ concentration or other gas or liquid concentration within theimplantable component, and pH within the implantable component. Theexternal clinical controller also may be configured to displayinformation indicative of the parameters based on the parameter signalsfrom the sensors. In addition, the non-transitory computer readablemedia may be configured to cause the graphical user interface to displayinformation indicative of the parameters based on the parameter signalsfrom the sensor and to display a waveform showing pressure versus timebased on the signal from the pressure transducer. The non-transitorycomputer readable media may be configured to run a routine to calculatepulmonary arterial compliance and to cause the graphical user interfaceto display the calculated pulmonary arterial compliance.

The compliant member may have any suitable shape including a cylindricalshape or a tapered shape configured to reduce billowing of the compliantmember. The implantable component may include an anchor configured tosecure the compliant member within the pulmonary artery. The anchor maybe coupled to the conduit proximal and/or distal to the compliant memberand may have any suitable shape, e.g., a plurality of petals. Thecompliant member may be configured to be detachable from at least aportion of the anchor in vivo such that the compliant member isreplaceable while at least the portion of the anchor remains implanted.Preferably, the anchor is configured to be delivered in a contractedstate within a sheath and to expand to a deployed state when exposedfrom the sheath.

In accordance with another aspect of the present disclosure, a method isprovided for treating heart disease, e.g., pulmonary hypertension, rightheart failure. The method may include providing an implantable componentcomprising a compliant member, a reservoir, and a conduit; implantingthe implantable component such that the compliant member is disposed ina pulmonary artery, the reservoir is disposed subcutaneously, and theconduit is coupled between the compliant member and the reservoir;providing an external clinical controller component comprising a fluidicconnector and a pressure transducer; coupling the fluidic connector tothe reservoir; measuring pressure within the reservoir using thepressure transducer; transmitting the measured pressure to a computer;and displaying information indicative of the measured pressure on agraphical user interface of the computer.

V. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of an exemplary embodiment of a systemconstructed in accordance with the principles of the present disclosure.

FIG. 2A shows an exemplary implantable component of the system of FIG.1.

FIG. 2B shows a cross-sectional view along line 2B in FIG. 2A of anexemplary reservoir.

FIGS. 2C through 2E show cross-sectional views along line 2C in FIG. 2Afor alternative conduits.

FIGS. 2F and 2G show an exemplary anchor of the implantable component ofFIG. 2A, where anchor is in an expanded state in FIG. 2F and contractedwithin a sheath in FIG. 2G.

FIG. 2H shows an alternative anchor for use with the implantablecomponent.

FIG. 21 shows an alternative balloon for use in the implantablecomponent wherein the balloon has a tapered shape.

FIGS. 2J though 2N show alternative anchors for use with the implantablecomponent.

FIG. 3 shows a generalized block diagram of an exemplary externalclinical controller component of the system of FIG. 1.

FIG. 4 is a block diagram of the functional components of an exemplarysoftware-based monitoring system of the system of FIG. 1.

FIG. 5 shows a generalized block diagram of an exemplary externalmonitoring component of the system of FIG. 1.

FIG. 6 shows an exemplary method for downloading and using a mobileapplication in accordance with the principles of the present disclosure.

FIGS. 7-11 are exemplary screenshots illustrating various aspects of thegraphical user interface of the software-based monitoring system of thepresent disclosure.

FIG. 12 shows an exemplary plot of pressure over time comparingpulmonary artery pressure of a calf when an implantable component isactivated versus deactivated.

FIG. 13 shows an exemplary plot of pressure over time comparingpulmonary artery pressure in a benchtop design when an implantablecomponent is activated versus deactivated.

VI. DETAILED DESCRIPTION OF THE INVENTION

Systems and methods of the present disclosure comprise implantabledevices for restoring compliance to a portion of a patient'svasculature, such as the pulmonary system, and external devices foradjusting and monitoring parameters of the implantable devices. Inaccordance with the principles of the present disclosure, the systemsmay be optimized for use in treating pulmonary hypertension (PH),including Pulmonary Arterial Hypertension (PAH) and Primary PH, andright heart failure (RHF).

Referring to FIG. 1, an overview of an exemplary system constructed inaccordance with the principles of the present disclosure is provided. InFIG. 1, components of the system are not depicted to scale on either arelative or absolute basis. System 100 may include implantable component200, external clinical controller component 300, software-basedmonitoring system 400, external monitoring component 500, and mobileapplication 600.

Implantable component 200 includes compliant member 202, reservoir 204,and conduit 206. Implantable component 200 may be a closed-loop, passivesystem and constructed similar to the components described in U.S.Patent Pub. No. 2013/0245665 to Scandurra, assigned to the assignee ofthe present disclosure, the entire contents of which are incorporatedherein by reference. Compliant member 202 is adapted to be implanted ina body lumen, e.g., the pulmonary artery, and reservoir 204 is adaptedto be implanted subcutaneously. Conduit 206 is configured to couplecompliant member 202 and reservoir 204 such that fluid may flow betweencompliant member 202 and reservoir 204 via conduit 206 in a closed-loopmanner in response to pressure changes in the body lumen during thecardiac cycle. In one embodiment, compliant member 202 is configured tocontract during systole and expand during diastole, thereby decreasingpeak pressure in the pulmonary artery, improving compliance of thepulmonary artery and the right side of the heart, and reducingremodeling of the pulmonary artery and the right side of the heart.

External clinical controller component 300 may include fluidic connector302, handle housing 304, actuation buttons 306, pressure transducer 308,pressure source 310, and processor housing 312. Fluidic connector 302 isconfigured to be coupled to implantable component 200, e.g., viareservoir 204, to permit fluidic communication with implantablecomponent 200.

Fluidic connector 302 may be a needle adapted to be insertedtranscutaneously into implantable component 200, e.g., via insertion ofthe needle into a septum of reservoir 204. In one embodiment, reservoir204 includes a conduit coupled to its internal cavity and configured toextend transcutaneously out of the patient, and fluidic connector 302 isa conduit configured to be coupled to the partially implanted conduit topermit fluid communication therebetween. In such an embodiment, repeatedskin penetration by fluidic connector 302 may be limited. The partiallyimplanted conduit may include a valve or cap configured to seal fluidwithin implantable component 200 when in a closed position.

Fluidic connector 302 is coupled to handle housing 304 which isconfigured to facilitate fluidic connector insertion. Handle housing 304may include a grip sized to be held by a human hand and may houseelectronics, one or more valves, one or more pumps, one or moreactuation buttons 306, and one or more pressure transducers 308 or,alternatively, one or more of those components may be housed inprocessor housing 312. Handle housing 304 also may be syringe-shaped andfurther include one or more plungers. Actuation buttons 306 areconfigured to be pressed to cause fluid from pressure source 310 to beinjected into implantable component 200 via fluidic connector 302. Forexample, pressing a first actuation button 306 may cause a valve betweenpressure source 310 and fluidic connector 302 to open to permit fluid toflow out of fluidic connector 302 or may cause a pump to activate tomove fluid in a first direction from pressure source 310 and out offluidic connector 302. As another example, pressing a second actuationbutton 306 may cause one or more valves to open or close and cause thepump to activate to create a vacuum and move fluid in a seconddirection, opposite the first, e.g., from implantable component 200,through fluidic connector 302, and into a waste reservoir. Whileactuation buttons 306 are illustrated as buttons, the present disclosureis not limited thereto and the actuation mechanism may be embodied in,for example, a trigger(s), a touch screen, or the like. Pressuretransducer 308 is disposed in fluid communication with fluidic connector302 such that pressure transducer 308 may generate a signal indicativeof pressure within implantable component 200 when fluidic connector 302is inserted in implantable component 200. Pressure source 310 is areservoir configured to hold fluid to be injected into implantablecomponent 200 through fluidic connector 302 when fluidic connector 302is in fluidic communication with implantable component 200. The fluidmay be a liquid or gas, which may be pressurized or compressed, andpressure source 310 may be permanently integrated in external clinicalcontroller component 300 or may be replaceable cartridges.

Handle housing 304 may be coupled, either wirelessly or using a cablesuch as cable 314, to processor housing 312. Processor housing 312 isconfigured to house processing electronics which may include signalfilters and components for wave shaping. For example, the electronicsmay receive the signal indicative of pressure and process the signal fordisplay and/or transmission to a computer. Processor housing 312 mayinclude user interface 316 for receiving user input relating toadjustments to functioning of component 300 and/or display of measuredparameters such as pressure within implantable component 200. As will bereadily understood by one skilled in the art, while handle housing 304and processor housing 312 are illustrated as two housings, thedisclosure is not limited thereto and handle housing 304 and processorhousing 312 may be integrated into one housing or separated into morethan two housings. In embodiments where fluid is configured to travelbetween handle housing 304 and processor housing 312; such as whenpressure source 310, a waste reservoir, and/or a pump is disposed inprocessor housing 312; cable 314 may include one or more lumens forfluid transfer or additional fluid cables may be used.

In FIG. 1, software-based monitoring system 400 is installed and runs ona conventional laptop computer, and is used by the patient's clinicianto monitor functioning of implantable components 200. During patientvisits, external clinical controller component 300 may be coupled,either wirelessly or using a cable such as cable 318, to the clinician'scomputer such that software-based monitoring system 400 may receive dataindicative of working parameters of implantable device 200.Software-based monitoring system 400 may be non-transitory computerreadable media configured to cause a graphical user interface to displayinformation indicative of measured parameters within implantablecomponent 200 based on signals received from sensors at implantablecomponent 200 and/or external clinical controller component 300, and mayalso receive signals from external monitoring component 500 via themobile device running mobile application 600. For example, thenon-transitory computer readable media may cause the graphical userinterface to display information indicative pressure within implantablecomponent 200 based on a signal from pressure transducer 308. Monitoringsystem 400 also may be configured to upload and store data retrievedregarding implantable component 200 to a remote server for later accessby the clinician.

External monitoring component 500 may include housing 502 and userinterface 504. External monitoring component 500 permits a user; e.g.,patient, clinician, caregiver; to monitor measured parameters withinimplantable component 200 at any time convenient for the patient.Housing 502 is configured to house electronics and may be shaped in anymanner to permit handheld use such as a disc with rounded edges asillustrated. Such electronics may include an inductive coil and/or RFtransceiver configured to communicate information in a bidirectionalmanner across a patient's skin to implantable component 200 and,optionally, to transmit power to electronics within implantablecomponent 200. For example, in an embodiment where a pressure sensor isdisposed within reservoir 204, external monitoring component 500 mayinclude inductive communication circuitry configured to wirelesslyactivate the pressure sensor to cause the pressure sensor to sense apressure within implantable component 200. The pressure sensor maytransmit a pressure signal indicative of the sensed pressure to externalmonitoring component 500 via the inductive coil or a RF transceiver. TheRF transceiver within housing 502 or an additional wireless transceiverwithin housing 502 may be configured for wireless communication; e.g.,via WiFi, Bluetooth, cellular, or the like; with corresponding wirelesscommunication circuitry in the mobile device running mobile application600 and/or the computer running monitoring system 400. User interface504 is configured to permit a user to provide user input to externalmonitoring component 500. User interface 504 may include a display andone or more buttons as illustrated, although the present disclosure isnot limited thereto. A user may, for example, press a button to causethe inductive communication circuitry to transmit power to a sensorwithin implantable component 200. After receipt of one or more signalsindicative of measured parameters from the sensor via communicationcircuitry, the display of user interface 504 may display the measuredparameter. Alternatively, or additionally, external monitoring component500 may transmit the one or more signals to mobile application 600.

Mobile application 600 is installed and runs on a conventional mobiledevice; e.g., smartphone, smart watch, tablet, laptop, or the like; andis used by the user to monitor functioning of internal components 200.External monitoring component 500 may be coupled, either wirelessly orusing a cable, to the user's mobile device such that mobile application600 receives data indicative of working parameters of implantable device200. Mobile application 600 may be non-transitory computer readablemedia configured to cause a graphical user interface to displayinformation indicative of measured parameters within implantablecomponent 200 based on signals received from sensors at implantablecomponent 200. For example, wireless communication circuitry within themobile device; e.g., WiFi circuitry, Bluetooth circuitry, cellularcircuitry or the like; may receive information indicative of pressurewithin implantable component 200 based on the pressure signal receivedat external monitoring component 500. User interface 602 of the mobiledevice may display the measured pressure, the status of implantablecomponent 200, and/or an alert if a measured parameter is above a firstpredetermined threshold or below a second predetermined threshold. Suchan alert may be transmitted to the clinician, e.g., via monitoringsystem 400, or may cause the mobile device to call the clinician or anemergency number for immediate patient assistance.

System 100 is configured to enhance monitoring of implantable component200 to assist in confirming proper functioning of implantable component200. For example, a clinician may determine an optimal internal pressurefor implantable component 200 on a patient-by-patient basis. Duringpatient visits, the clinician may confirm that the pressure withinimplantable component 200 is within a predetermined range around theoptimal internal pressure using external clinical controller 300 andmonitoring system 400. If not, the clinical may make adjustments topressure by introducing or removing fluid using external clinicalcontroller 300. The clinician may also remove fluid from withinimplantable component 200 using external clinical controller 300 after apredetermined time period; e.g., weekly, monthly, yearly, during eachvisit; and introduce new fluid using external clinical controller 300 toachieve the optimal internal pressure or an adjusted optimal internalpressure as treatment progresses.

System 100 is designed to restore compliance to the pulmonary system.Implantable component 200 is configured to reduce the pressure that theright ventricle must work against, thereby increasing cardiac output andslowing disease progression, and the remaining components of system 100help ensure that implantable component is functioning suitably.Implantable component 200 also is configured to increase the diastolicpressure and slow the pulse wave such that the reflected waves do notcontribute to afterload. It is expected that implantable component 200will reduce the load on the heart and allow the heart to pump more bloodusing less energy; thereby preventing, delaying, or potentiallyreversing right heart failure.

Referring now to FIG. 2A, an exemplary embodiment of implantablecomponent 200 is described. Implantable component 200 includes compliantmember 202, reservoir 204, and conduit 206. Compliant member 202 isadapted to be implanted in a body lumen, e.g., the pulmonary arterywhich includes the main pulmonary artery and the pulmonary arterybranches. Compliant member 202 is preferably a compliant orsemi-compliant balloon and may be formed from a polymer, an elasticmaterial, e.g., rubber, and/or a flexible but inelastic material, e.g.,metalized mylar. Compliant member 202 may have a single layer wall ormultiple layers of multiple materials with one or more layers beingformed of composite materials with reinforcing fibers. Compliant member202 has a maximum diameter, a length, and a wall thickness. Preferably,compliant member 202 has a maximum diameter between about 1.5-3.5 cm,and preferably about 2.5 cm; a length between about 3-8 cm, andpreferably about 4.5-5 cm; and a wall thickness between about0.001-0.020 inches. Compliant member 202 preferably has a diameter inthe fully expanded state that is less than the diameter of the pulmonaryartery. For example, the diameter of compliant member 202 in the fullyexpanded state may be between about 20-90%, about 30-80%, about 40-75%,about 50-70%, about 55-70%, about 60-70%, or about 65% of the diameterof the pulmonary artery in the area at which compliant member 202 isimplanted. Applicant has discovered that utilizing a compliant membersized such that the ratio of the inner diameter of the body lumen to themaximum balloon diameter is below a predetermined threshold; e.g., about0.9, about 0.875, about 0.85, about 0.825, about 0.8, about 0.75, about0.7, about 0.65, or about 0.6; maintains pressure upstream from thecompliant member at a level substantially similar to pressure downstreamfrom the compliant member; thereby regulating pressure drop across thecompliant member during the cardiac cycle. Compliant member 202 ispreferably sized with a maximum diameter that will not obstruct bloodflow or increase resistance to flow in the pulmonary artery.

With each heartbeat, fluid within implantable component 200 movestowards or away from compliant member 202. By contracting and gettingsmaller in volume, compliant member 202 mimics the expansion of thevessel (increasing intravascular volume) that would naturally occur in ahealthy person, making room for incoming blood. When the heart begins torelax, the pulmonary valve closes and the pressure in the main pulmonaryartery begins to drop. As the pressure drops below the pressure level inreservoir 204, fluid flows from reservoir 204 to compliant member 202such that the potential energy within compliant member 202 increases.During diastole, compliant member 202 preferably expands to about itsfull volume to increase pressure in the pulmonary artery to pushadditional blood through the lungs. Continuous expansion and contractionof compliant member 202 is expected to reduce peak systolic pressure andincrease diastolic pressure, thereby reducing the load on the rightventricle and increasing heart efficiency.

Compliant member 202 may be secured within the body lumen via anchor208. Anchor 208 may be coupled to compliant member 202, to conduit 206proximal to compliant member 202, and/or to conduit 206 distal tocompliant member 202 as illustrated. Preferably, anchor 208 isconfigured to expand from a contracted state, e.g., when compressed in asheath, to an expanded state responsive to an event, e.g., exposure fromthe sheath or expansion of compliant member 202. In the expanded state,anchor 208 is sized to contact the inner wall of the body lumen oranother anchor deployed within the body lumen as described in detailbelow.

Reservoir 204 is configured to receive and hold a fluid, e.g., liquid orgas, therein. Reservoir 204 includes housing 210, septum 212, and port214. Housing 210 is hermetically sealed and may comprise titanium orother biocompatible material. Reservoir 204 is configured to beimplanted subcutaneously in a suitable body cavity, e.g., within asubcutaneous space in a region near the right or left subclavian vein.Although any suitable shape may be used, in one exemplary embodiment,reservoir 204 has a flattened disk shape with rounded edges to reducebodily irritation. The interior cavity of reservoir 204 is in fluidiccommunication with the interior cavity of compliant member 202, e.g.,via one or more lumens of conduit 206, such that fluid may move betweenthe cavities and/or pressure may equalize between the cavities.Preferably, the interior cavity of reservoir 204 has a volume of about40-250 ml, about 40-150 ml, about 40-100 ml, about 40-70 ml, or about 60ml.

Septum 212 is structured and operable to allow the addition of fluid toor the removal of fluid from reservoir 204. Septum 212 is preferablyimplanted underneath the patient's skin to permit transcutaneous needleaccess to the interior cavity of reservoir 204 through septum 212.

Septum 212 is configured to permit repeated needle penetrations whilemaintaining a gas-tight seal and may be formed from any suitablematerial or materials that reduces diffusion of fluid from the internalcavity of reservoir 204. Radiopaque, magnetic, acoustic, or othermarkers may also be incorporated into or attached to septum 204 to allowfor locating, viewing or tracking of septum 204 with a suitable imagingor sensing system.

Port 214 of reservoir 204 is configured to permit fluidic communicationbetween conduit 206 and the interior cavity of reservoir 204. Port 214may include a suitable structure to permit coupling between conduit 206and reservoir 204 such as a nipple (as illustrated), threads, ribs, orthe like.

Referring now to FIG. 2B, a cross-sectional view of reservoir 204 alongline 2B in FIG. 2A is shown. Interior cavity 220 of reservoir 204 mayhave sensor 222, sensor 224, and getter 226. Sensors 222, 224 areconfigured to sense one or more parameters of implantable component 200such as pressure and/or volume within reservoir 204. Such parameters maybe used to assist in removing fluid or introducing fluid to achieve theoptimal internal pressure or to confirm proper functioning ofimplantable component 200. Additional parameters that may be sensedwithin reservoir 204 include temperature, humidity, fluid flow rate, gasor liquid concentration such as CO₂ concentration, and pH. Sensors 222and 224 may include an inductive coil and may be configured to bepowered by an external inductive coil, e.g., coil within externalmonitoring component 500. In such an embodiment, sensors 222, 224 mayremain off or in a standby mode until receipt of power; after whichsensors 222, 224 sense one or more parameters and transmit one or moresignals indicative of the sensed parameters externally, e.g., toexternal monitoring component 500, via respective inductive coils. In apreferred embodiment, sensor 222 is a pressure sensor configured tomeasure pressure within reservoir 204. Measured pressure may bedisplayed and analyzed externally.

Getter 226 is configured to absorb moisture within reservoir 204.Unwanted moisture from within the body may enter implantable component200 after implantation. Preferably when the fluid is a gas, getter isconfigured to absorb liquids within reservoir 204. Getter 226 may beremoved, e.g., via fluidic connector 302, and replaced with anothergetter, e.g., via fluidic connector 302, after a period of time.

Referring back to FIG. 2A, conduit 206 is configured to couple compliantmember 202 to reservoir 204. Conduit 206 includes proximal region 216and distal region 218. In the illustrated embodiment, conduit 206 iscoupled to port 214 of reservoir 204 at proximal region 216 and coupledcompliant member 202 at distal region 218. Preferably, conduit 206 has asuitable length to extend from reservoir 204 in the subcutaneous space,through the subclavian vein, and past the pulmonary valve to compliantmember 202 implanted within the pulmonary artery. Preferably, conduit206 extends through and past compliant member 202 a predetermineddistance and includes one or more ports in the portion of conduit 206within compliant member 202 to permit fluid to be introduced fromconduit 206 into the interior space of compliant member 202. In oneembodiment, conduit 206 has a length between about 20-70 cm, about 30-70cm, about 40-70 cm, about 50-60 cm, or about 55 cm. The diameter ofconduit 206 is preferably about 3-5 mm or about 4 mm at distal regionand may be variable along the length of conduit 206 up to apredetermined maximum diameter, e.g., about 15 mm. Preferably, conduit206 has a wall thickness between about 0.005 to 0.020 inches.

Referring now to FIG. 2C, 2D, and 2E, cross-sectional views ofalternative conduits along line 2C in FIG. 2A are shown wherein thenumber of lumens within the conduits vary. In FIG. 2C, conduit 206 haslumen 230. Lumen 230 is configured to permit fluid to move back andforth between compliant member 202 and reservoir 204. Lumen 230preferably extends from proximal region 216 to a port within compliantmember 202. Conduit 206 also may include a second lumen (notillustrated) sized to permit a guidewire and/or a balloon retrievaldevice to be advanced therethrough that preferably extends from theproximal end of conduit 206 out the distal end of conduit 206 pastcompliant member 202. Referring to FIG. 2D, conduit 206′ is constructedsimilarly to conduit 206 of FIG. 2C, wherein like components areidentified by like-primed reference numbers. As will be observed bycomparing FIGS. 2C and 2D, conduit 206′ includes three lumens; guidewirelumen 232, inflow lumen 234, and outflow lumen 236. Guidewire lumen 232is sized to permit a guidewire and/or a balloon retrieval device to beadvanced therethrough and preferably extends from the proximal end ofconduit 206 out the distal end of conduit 206 past compliant member 202.Inflow lumen 234 is configured to permit fluid to move only fromreservoir 204 to compliant member 202, e.g., using one-way valve 238.Inflow lumen 234 preferably extends from proximal region 216 to a portwithin compliant member 202. Outflow lumen 236 is configured to permitfluid to move only from compliant member 202 to reservoir 204, e.g.,using one-way valve 240 disposed in an opposite direction to valve 238.Outflow lumen 236 preferably extends from proximal region 216 to a portwithin compliant member 202. Referring to FIG. 2E, conduit 206″ isconstructed similarly to conduit 206′ of FIG. 2D, wherein likecomponents are identified by like-primed reference numbers. As will beobserved by comparing FIGS. 2D and 2E, conduit 206″ includes a fourthlumen: lumen 242. Lumen 242 is configured to permit a balloon retrievaldevice to be advanced therethrough and has a diameter larger thanguidewire lumen 232′.

Referring now to FIG. 2F, a front view of anchor 208 of implantablecomponent 200 in FIG. 2A is provided. Anchor 208 is coupled to conduit206 between the distal end of compliant member 202 and distal end 244 ofconduit 206. Anchor 208 may comprise shape memory material, e.g.,nitinol, and is preferably configured to self-expand when exposed from asheath. Illustratively, anchor 208 includes five petals 246 althoughmore or fewer petals may be used. In FIG. 2F, anchor 208 is shown in anexpanded state. In the expanded state, the distal regions of petals 246are sized to contact the inner wall of the body lumen, e.g., pulmonaryartery, or another anchor deployed within the body lumen.

In FIG. 2G, the distal region of implantable component 200 is shown in acontracted state. Preferably, compliant member 202 is in a contracted,deflated state when disposed within sheath 250. After deployment,compliant member 202 may be expanded by introduction of fluid fromreservoir 204 through port 248. When compressed within sheath 250,anchor 208 bends distally away from compliant member 202. Anchor 208 isconfigured to expand to the expanded state when the distal end of sheath250 is refracted proximally past anchor 208 or when anchor 208 is pusheddistally out of the distal end of sheath 250. After deployment of anchor208 and compliant member 202 past the distal end of sheath 250, sheath250 may be removed from the patient or sheath 250 may be permanentlyimplanted at a position such that the distal end of sheath 250 does notinterfere with expansion of compliant member 202 or anchor 208 and theproximal end of sheath 250 does not interfere with coupling the proximalend of conduit 206 to reservoir 204. After deployment, sheath 250, oranother similar sheath, may be advanced distally, or conduit 206 pulledproximally, such that compliant member 202 and anchor 208 enter thelumen of sheath 250 at its distal end to return anchor 208 to thecontracted state. Conduit 206 and compliant member 202, including anchor208, then may be retrieved from sheath 250, e.g., by detaching theproximal end of conduit 206 from reservoir 204 and pulling the proximalend of conduit 206 proximally out the proximal end of sheath 250. Ifdesired, a replacement conduit and/or replacement compliant member maybe introduced into the patient through sheath 250 and then attached toreservoir 204 at the proximal end of the replacement conduit.

Referring to FIG. 2H, compliant member 202′ and conduit 206″' areconstructed similarly to compliant member 202 and conduit 206 of FIG.2F, wherein like components are identified by like-primed referencenumbers. As will be observed by comparing FIGS. 2F and 2H, anchor 208′is shaped to surround compliant member 202′ rather than disposeddistally to the compliant member. Anchor 208′ is coupled to conduit206″′ distal to compliant member 202′ and coupled to conduit 206″′proximal to compliant member 202′. Anchor 208′ is configured to radiallyexpand from a contracted state, e.g., when compressed in a sheath, to anexpanded state responsive to an event, e.g., exposure from the sheath orexpansion of compliant member 202′. In the expanded state, the outersurface of anchor 208′ is sized to contact the inner wall of the bodylumen. In one embodiment, the outer portion of anchor 208′ has a lengthsubstantially similar to the length of compliant member 202′.

Referring to FIG. 21, conduit 206″″ is constructed similarly to conduit206 of FIG. 2F, wherein like components are identified by like-primedreference numbers. As will be observed by comparing FIGS. 2F and 21,anchor 208 is not shown for simplicity and compliant member 202″ has atapered shape along a substantial portion of its length rather than acylindrical shape. Compliant member 202″, shown in the expanded state,has large diameter end 252, small diameter end 254, and a slopingportion therebetween. Preferably, compliant member 202″ is implanted inthe body lumen such that blood flows from small diameter end 254 towardslarge diameter end 252. The tapered shape of compliant member 202″ isconfigured to reduce billowing of compliant member 202″ caused byejection of blood during systole. As will be understood by one ofordinary skill, while compliant member 202 has a cylindrical shape andcompliant member 202″ has a tapered shape, the present disclosure is notlimited thereto and additional balloon shapes are contemplated herein.

Referring to FIG. 2J, compliant member 202″′ and conduit 206 areconstructed similarly to compliant member 202 and conduit 206 of FIG.2F, wherein like components are identified by like-primed referencenumbers. As will be observed by comparing FIGS. 2F and 2J, anchor 208″is shaped in a rolled manner and includes arms 260 and 262. In FIG. 2J,anchor 208″ is contracted within sheath 250′ and introduced into thepulmonary artery PA for implantation. In the contracted state, arms 260and 262 roll radially inward toward conduit 206 . When exposed fromsheath 250′, arms expand radially outward such that a distal region ofarms 260 and 262 contact the inner wall of the pulmonary artery as shownin FIG. 2K. Arms 260 and 262 may be constructed with a shape memorymaterial and may self-expand to resemble an “S” shape in the expandedstate. In one embodiment, arms 260 and 262 are constructed similarly tothe anchors of U.S. Pat. No. 4,666,445 to Tillay, the entire contents ofwhich are incorporated herein by reference. Arms 260 and 262 may becoupled to conduit 206 distal to compliant member 202″' as illustratedor proximal to compliant member 202″′. Alternatively, additional armsmay be used, including two arms disposed distal to the compliant memberand two arms disposed proximal to the compliant member. In FIG. 2K,compliant member 202″′ is shown in an expanded state.

FIG. 2L is a side view of the components of FIG. 2K where arms 260 and262 are in the expanded state. Arms 260 and 262 each has a width largeenough to suitably anchor compliant member 202″' stably within thepulmonary artery PA.

Alternatively, arms 260′ and 262′ may be wire-like and have a relativelythin width. In such an embodiment, arms 260′ and 262′ may be anchoredwithin a previously deployed anchor, e.g., anchor 270 shown in FIGS. 2Mand 2N. Anchor 270 illustratively includes protrusions 272 and 274 andgroove 276 disposed between protrusions 272 and 274. In one embodiment,protrusions 272 and 274 have an annular shape. Anchor 270 is configuredto radially expand from a contracted state, e.g., when compressed in asheath, to an expanded state responsive to an event, e.g., exposure fromthe sheath or expansion of compliant member 202″″. In the expandedstate, the outer surface of anchor 270 is sized to contact the innerwall of the body lumen, e.g., the pulmonary artery PA as shown in FIG.2M. After deployment of anchor 270, the anchor coupled to the conduitmay be anchored to anchor 270. For example, compliant member 202″″ maybe advanced in a sheath when arms 260′ and 262′ are in the contractedstate. When arms 260′ and 262′ are aligned within groove 276, the sheathis pulled proximally such that arms 260′ and 262′ expand radiallyoutward and contact groove 276 as shown in FIG. 2N.

Protrusions 272 and 274 are configured to maintain arms 260′ and 262′within groove 276. The distal end of the sheath, arms 260′ and 262′,and/or protrusions 272 and 274 may include radiopaque markers to permitvisualization during delivery to assist in proper alignment. In oneembodiment, arms 260, 260′, 262, and 262′ are configured to roll back tothe contracted state when the conduit is rotated to facilitate insertionof the arms within the sheath for conduit and compliant member removal.In such an embodiment, arms 260, 260′, 262, and 262′ are configured toradially expand when the conduit is rotated in a first direction, e.g.,clockwise, and to radially contract when the conduit is rotated in asecond direction, opposite the first direction, e.g., counterclockwise.

Implantable component 200 may be used together with drugs, such asanticoagulants, to reduce the risk of pulmonary emboli. Advantageously,implantable component 200 is expected to provide one or more of thefollowing patient benefits through increased pulmonary vascularcompliance: (i) decreased stress on the heart—as blood is ejected intothe main pulmonary artery, compliant member 202 is compressed, mimickinghow a healthy pulmonary artery expands to make room for incoming blood,thereby reducing systolic pressure; (ii) increased cardiacoutput—decreased load on the heart caused by repeated expansion andcontraction of compliant member 202 allows more blood to flow to thelungs; (iii) decreased workload on the heart—repeated expansion andcontraction of compliant member 202 reduces the mechanical work requiredto pump blood thereby redistributing work load in the right ventricle toreduce or prevent right ventricular remodeling, e.g., conversion ofelastin to collagen; (iv) slowed progression of PH—repeated expansionand contraction of compliant member 202 reduces the cyclic strain on thesmall pulmonary arteries to slow the progression of vascular thickeningand/or remodeling caused by PH; (v) immediate effectiveness—in contrastto drug therapy, implantable component 200 is configured to decrease theworkload on the heart immediately upon implantation and may be utilizedin emergency situations; and (vi) effective even in advanced cases ofPAH.

Implantable component 200 may be implanted within a patient such thatcompliant member 202 is positioned within the pulmonary artery distal tothe pulmonary valve, reservoir 204 is positioned within a subcutaneousspace, and conduit 206 extends from reservoir 204 through the subclavianvein to, and potentially past, compliant member 202. For implantation,an incision may be made in the subclavicular skin, e.g., under thecollarbone, and a pocket formed in the subcutaneous space. Then, anincision may be made in the subclavian vein. Upon forming the first andsecond incisions, a guidewire may be inserted into the subclavian veinand through the venous system such that the distal end of the guidewireis positioned in the pulmonary artery distal to the pulmonary valve.Using fluoroscopy, acoustic, anatomic, or CT guidance, throughout theprocedure, sheath 250 then may be delivered over the guidewire. Next,compliant member 202 coupled to conduit 206 may be advanced throughsheath 250 until compliant member 202 is extracted out the distal end ofsheath 250. Alternatively, compliant member 202 and conduit 206 may bepre-loaded within sheath 250 external to the patient's body and advancedover the guidewire together. In such a configuration, sheath 250 may beretracted to expose compliant member 202 at the desired position withinthe pulmonary artery or compliant member may be advanced distally out ofthe distal end of sheath 250 at the desired position within thepulmonary artery. With compliant member 202 positioned in the desiredresting position, e.g., via anchor 208, sheath 250 and the guidewire maybe removed. Alternatively, sheath 250 may remain implanted to facilitateremoval of conduit 206 and compliant member 202 and introduction ofreplacement conduits and compliant members. Reservoir 204 may then becoupled to conduit 206 and placed in the subcutaneous pocket and theincisions closed. Fluid may be injected into the septum of reservoir 204until a desired internal pressure is reached before or after theincisions are closed.

Referring to FIG. 3, a generalized schematic diagram of the internalfunctional components of external clinical controller component 300 isnow described. External clinical controller component 300 may includeprogrammable controller 330, extraction lumen 332 where fluid moves indirection 334, injection lumen 336 where fluid moves in direction 338,system sensors 340, valves 342, fluid movement mechanism 344, pressuresource 346, waste reservoir 348, user interface 350, communications unit352, input and output circuitry (I/O) 354, filtering and wave formingunit 356, and power supply 358.

Programmable controller 330 is electrically coupled to, and configuredto control, the internal functional components of external clinicalcontroller component 300. Controller 330 may comprise one or morecommercially available microcontroller units that may include aprogrammable microprocessor, volatile memory, nonvolatile memory such asEEPROM for storing programming, and nonvolatile storage, e.g., Flashmemory, for storing firmware and a log of system operational parametersand patient data. The memory of controller 330 stores programinstructions that, when executed by the processor of controller 330,cause the processor and the functional components of external clinicalcontroller component 300 to provide the functionality ascribed to themherein. Controller 330 is configured to be programmable such thatprogramming data is stored in the memory of controller 330 and may beadjusted using monitoring system 400. As will be readily understood toone skilled in the art, while FIG. 3 is illustrated to show oneprogrammable controller, multiple programmable controllers may beutilized. For example, in an embodiment where the handle housing andprocessor housing are separate, each housing may include at least oneprogrammable controller.

Extraction lumen 332 is configured to permit fluid to move therethroughin direction 334, e.g., away from implantable component 200, andpreferably extends from the distal end of fluidic connector 302 to wastereservoir 348. Extraction lumen 332 may be coupled to one or moresensors of system sensors 340, one or more valves of valves 342, fluidmovement mechanism 344, and/or waste reservoir 348.

Injection lumen 336 is configured to permit fluid to move therethroughin direction 338, e.g., towards implantable component 200, andpreferably extends from the distal end of fluidic connector 302 topressure source 346. Injection lumen 336 may be coupled to one or moresensors of system sensors 340, one or more valves of valves 342, fluidmovement mechanism 344, and/or pressure source 346. As will be readilyunderstood by one skilled in the art, while FIG. 3 shows extractionlumen 332 and injection lumen 336 as separate, they may be integratedinto a common lumen.

System sensors 340 are configured to sense one or more parameters ofimplantable component 200 such as pressure and/or volume withinreservoir 204. System sensors 340 may generate one or more signalsindicative of the sensed parameter(s) for processing and/or transmissionto monitoring system 400. In one embodiment, such sensors are configuredto sense the parameters when fluidic connector 302 is inserted intoreservoir 204 through septum 212. Such parameters may be used to assistin removing fluid or introducing fluid to achieve an optimal internalpressure within implantable component 200 or to confirm properfunctioning of implantable component 200. Parameters of implantablecomponent 200 that may be sensed by system sensors 340 also may includetemperature, humidity, fluid flow rate, volume of injected fluid, volumeof extracted fluid, gas or liquid concentration such as CO₂concentration, and pH. System sensors 340 may include pressuretransducer 308 and are preferably disposed in fluidic communication withthe fluidic connector lumen(s), e.g., extraction lumen 332 and/orinjection lumen 336. In a preferred embodiment, when fluidic connector302 is inserted into reservoir 204, the pressure transducer isconfigured to measure pressure within reservoir 204.

Valves 342 are configured to permit fluid to flow therethrough whenopened and to prevent fluid flow therethrough when closed. In oneembodiment, a one-way valve is disposed in extraction conduit 332 andconfigured to permit fluid to flow in direction 334 when opened. Inaddition, or alternatively, a one-way valve may be disposed in injectionconduit 336 and configured to permit fluid to flow in direction 338 whenopened. Valves 342 may be opened in response to user input received atuser interface 350. For example, pressing a first actuation button ofuser interface 350 may cause a valve in injection lumen 336 to open topermit fluid to flow out of fluidic connector 302. As another example,pressing a second actuation button of user interface 350 may cause avalve in extraction lumen 334 to open and, optionally, cause fluidmovement mechanism 344 to activate to create a vacuum and move fluid indirection 334.

Fluid movement mechanism 344 may be any suitable mechanism for movingfluid in a forward direction and a reverse direction. For example, fluidmovement mechanism 344 may be a bidirectional pump, a unidirectionalpump, two unidirectional pumps configured to pump fluid in oppositedirections, a plunger, two plungers configured to move fluid in oppositedirections, or the like. Fluid movement mechanism 344 may be activatedresponsive to user input received at user interface 350 to move fluidfrom pressure source 346 and out the distal end of fluidic connector302. In one embodiment, user input received at user interface 350 causesa pump to move fluid in direction 338, e.g., towards and intoimplantable component 200. In another embodiment, a clinician presses aplunger to move fluid from pressure source 346 in direction 338, e.g.,towards and into implantable component 200. In an embodiment where fluidwithin pressure source 346 is pressurized, fluid movement mechanism 344need not necessarily be used to move fluid. Fluid movement mechanism 344also may be activated responsive to user input to move fluid in anopposite direction from implantable component 200, into the distal endof fluidic connector 302, and into waste reservoir 348. In oneembodiment, user input received at user interface 350 causes a pump tomove fluid in direction 334, e.g., out of and away from implantablecomponent 200. In another embodiment, a clinician pulls a plunger tomove fluid from within implantable component 200 in direction 334, e.g.,out of and away from implantable component 200.

Pressure source 346 is a reservoir configured to hold fluid to beinjected into implantable component 200 through fluidic connector 302when fluidic connector 302 is in fluidic communication with implantablecomponent 200, e.g., by piercing the septum of reservoir 204. Pressuresource 346 may correspond to pressure source 310 of FIG. 1. The fluid ispreferably a biocompatible gas or biocompatible liquid and may includecarbon dioxide (CO₂), air, oxygen, nitrogen, saline, water, or the like.The fluid may be selected to reduce the risk of diffusion through theouter walls of compliant member 202, reservoir 204, and/or conduit 206.The fluid may be pressurized or compressed and pressure source 346 maybe refillable and permanently integrated in external clinical controllercomponent 300 or may be replaceable cartridges, e.g., CO₂ cartridges.

Waste reservoir 348 is configured to hold fluid extracted from withinimplantable component 200 through fluidic connector 302 when fluidicconnector 302 is in fluidic communication with implantable component200, e.g., by piercing the septum of reservoir 204. For example, wastereservoir 348 may hold moisture that had accumulated within implantablecomponent 200 and/or getter 226 that had absorbed moisture in reservoir204.

User interface 350 is configured to receive user input and, optionally,to display information to the user. User interface 350 may includebuttons for receiving user input, such as actuation buttons 306 orbuttons of user interface 316, and a display for displaying informationto the clinician, e.g., display of user interface 316 in FIG. 1. As willbe readily apparent to one skilled in the art, user interface 350 is notlimited thereto and may use one or more of a trigger, a plunger, a touchscreen, a keypad, a microphone, a speaker, a trackball, or the like.

Communication unit 352 is configured to transmit information, such assignals indicative of sensed parameters and the like, to a remotelocation such as a computer running monitoring system 400. Communicationunit 352 may include circuitry; e.g., WiFi, Bluetooth, and/or cellularchipsets; configured for wireless communication over a network such asthe Internet, a local network, or a telephone network using techniquesknown in the art.

Input and output circuitry (I/O) 354 may include ports for datacommunication such as wired communication with a computer and/or portsfor receiving removable memory, e.g., SD card, upon which programinstructions or data related to external clinical controller component300 use may be stored. In one embodiment, I/O 354 comprises ports, andcorresponding circuitry, for accepting cables 314 and 318 such thatexternal clinical controller component 300 is electrically coupled to acomputer running software-based monitoring system 400.

Filtering and wave forming unit 356 is configured to receive signalsindicative of sensed parameters, e.g., from system sensors 340, and toprocess the signals. For example, filtering and wave forming unit 356may include one or more filters configured to filter noise from thesignals. Filtering and wave forming unit 356 also may include waveshaping processing circuitry known in the art for processing a signalfor display of the measured parameter as a wave. For example, filteringand wave forming unit 356 may process a signal indicative of real-timesensed pressure within implantable component 200 such that a real-timepressure wave may be displayed on user interface 350 and/or on thedisplay of the computer running monitoring system 400.

Power supply 358 powers the electrical components of external clinicalcontroller component 300, and may comprise a primary cell or battery, asecondary (rechargeable) cell or battery or a combination of both.Alternatively, power supply 358 may be a port to allow external clinicalcontroller component 300 to be plugged into a conventional wall socketfor powering components. In one embodiment, power supply 358 comprisesone or more ports and one or more cables that enable external clinicalcontroller component 300 to be powered from the computer, e.g., viacables 314 and 318, running software-based monitoring system 400.

Referring now to FIG. 4, the software implementing monitoring system 400is now described. The software of monitoring system 400 comprises anumber of functional blocks, schematically depicted in FIG. 4, includingmain block 402, event logging block 404, data download block 406,configuration setup block 408, user interface block 410, alarm detectionblock 412, sensor calibration block 414, firmware upgrade block 416,device identifier block 418, and status information block 420. Thesoftware preferably is written in C++ and employs an object orientedformat. In one preferred embodiment, the software is configured to runon top of a Microsoft Windows™ (a registered trademark of MicrosoftCorporation, Redmond, Wash.) or Unix-based operating system, such as areconventionally employed on desktop and laptop computers. The computerrunning monitoring system 400 preferably includes a data port, e.g., USBport or comparable wireless connection, that permits external clinicalcontroller component 300, external monitoring component 500, and/or themobile device running mobile application 600 to be coupled thereto.Alternatively, or additionally, the computer may include wirelesscircuitry; e.g., conforming to the IEEE 802.11 standards, the 3G, 4G,LTE, or other cellular standards, and/or Bluetooth standards; therebyenabling external clinical controller component 300, external monitoringcomponent 500, and/or the mobile device running mobile application 600to communicate wirelessly with the computer running monitoring system400.

Main block 402 preferably includes a main software routine that executeson the clinician's computer, and controls overall operation of the otherfunctional blocks. Main block 402 enables the clinician to downloadevent data and alarm information stored on external clinical controllercomponent 300, external monitoring component 500, and/or the mobiledevice running mobile application 600 to his office computer, and alsopermits monitoring system 400 to receive signals indicative of sensedparameters from external clinical controller component 300, externalmonitoring component 500, and/or the mobile device running mobileapplication 600. Main block 402 further is configured execute routinesto calculate parameters based on sensed parameters. For example, mainblock 402 is configured to execute a routine to calculate volume withinimplantable component 200 (e.g., compliant member 202, reservoir 204)using signals indicative of pressure sensed at implantable component 200and known equations, such as Boyle's law. Other parameters may becalculated using sensed parameters such as pulmonary arterial compliance(PAC), added PAC, native PAC, mean pressure, systolic pressure,diastolic pressure, fluid diffusion rate, liquid penetration rate,compliant member collapse percentage, compliant member expanded volume,compliant member contracted volume, and compliant member total volume.Main block 402 further is configured execute routines to calculate datafor display based on input received at User Interface block 410. Forexample, a clinician may enter implantable component 200 implantationdate, implantable component 200 activation date, and time to nextpatient visit and routines are run to determine time since activationbased on the activation date, time to recommended replacement based onthe implantation and/or activation date, and the time to next patientvisit. Main block 402 also enables the clinician to upload firmwareupdates and configuration data to external clinical controller component300, external monitoring component 500, and/or the mobile device runningmobile application 600.

Event Log block 404 is a record of operational data downloaded fromexternal clinical controller component 300, external monitoringcomponent 500, and/or the mobile device running mobile application 600,and may include, for example, measurement times, real-time sensedparameters, parameters previously sensed, sensor data, battery current,battery voltage, battery status, and the like. The event log also mayinclude the occurrence of events, such as alarms or other abnormalconditions. Event Log block 404 may further include a record of datainputted at User Interface block 410 such as patient information,implantable component 200 implantation date, implantable component 200activation date, and time to next patient visit.

Data Download block 406 is a routine that commands external monitoringcomponent 500 and/or the mobile device running mobile application 600 totransfer data to monitoring system 400 for download after externalclinical controller component 300 is coupled to the computer runningmonitoring system 400. Data Download block 406 may initiate, eitherautomatically or at the instigation of the clinician via user interfaceblock 410, downloading of data stored in the event log.

Configuration Setup block 408 is a routine that configures theparameters stored within external clinical controller component 300,external monitoring component 500, and/or the mobile device runningmobile application 600 that control operation of the respectivecomponent/application. The parameters may determine, e.g., how longsince a user sensed parameters within implantable component 200 and, ifpast a predetermined threshold, may alert the user. Such interval timingparameters may be reconfigured by block 408. Interval timing settingstransmitted to external clinical controller component 300, externalmonitoring component 500, and/or the mobile device running mobileapplication 600 from monitoring system 400 also may determine when andhow often event data is written to the memory in the respectivecomponent/application.

User interface block 410 handles receipt of user input at the computerrunning monitoring system 400 and display of information retrieved fromexternal clinical controller component 300, external monitoringcomponent 500, and/or the mobile device running mobile application 600,and data download block 406, and presents that information in anintuitive, easily understood format for clinician review such asnumbers, wave forms, text, a plot, a chart, a graph, or the like. Suchinformation may include status of external clinical controller component300, status of external monitoring component 500, status of mobileapplication 600, patient information, implant timing information, timeto implant replacement, measurement times, real-time sensed parameters,parameters previously sensed, parameters calculated using sensedparameters, sensor data, battery current, battery voltage, batterystatus, and the like.

Alarm detection block 412 may include a routine for evaluating the dataretrieved from external clinical controller component 300, externalmonitoring component 500, and/or the mobile device running mobileapplication 600 and flagging abnormal conditions for the clinician'sattention. For example, alarm detection block 412 may flag when aparameter sensed by system sensors 340, or sensors 222, 224, is above afirst predetermined threshold or below a second predetermined threshold.

Sensor calibration block 414 may include a routines for testing ormeasuring drift, of system sensors 340 or sensors 222, 224, e.g., due toaging or change in humidity. Block 414 may then compute offset valuesfor correcting measured data from the sensors, and transmit thatinformation to sensors 222, 224 or external clinical controllercomponent 300 for storage in the nonvolatile memory of controller 330.

Firmware upgrade block 416 may comprise a routine for checking theversion numbers of the controller firmware installed on externalclinical controller component 300, external monitoring component 500,and/or the mobile device running mobile application 600, and identifywhether upgraded firmware exists. If so, the routine may notify theclinician and permit the clinician to download revised firmware toexternal clinical controller component 300, external monitoringcomponent 500, and/or the mobile device running mobile application 600,in nonvolatile memory.

Device identifier block 418 consists of a unique identifier forimplantable component 200 that is stored in an RFID coupled toimplantable component 200 and a routine for reading that data whenmonitoring system 400 is coupled to an RFID reader, e.g., in externalclinical controller component 300. The device identifier also may beused by implantable component 200 to confirm that wirelesscommunications received from external monitoring component 500 areintended for that specific device. Likewise, this information isemployed by external monitoring component 500 to determine whether areceived message was generated by implantable component 200 associatedwith that system. Alternatively, the device identifier may be inputtedat User Interface block 410 and stored in memory of the computer runningmonitoring system 400.

Status information block 420 comprises a routine for interrogatingexternal clinical controller component 300, external monitoringcomponent 500, and/or the mobile device running mobile application 600to retrieve current status data from external clinical controllercomponent 300, external monitoring component 500, and/or the mobiledevice running mobile application 600, respectively. Such informationmay include, for example, battery status, version control informationfor the firmware and hardware currently in use, and sensor data.

Referring to FIG. 5, a generalized schematic diagram of the internalfunctional components of external monitoring component 500 is nowdescribed. External monitoring component 500 may include programmablecontroller 510, telemetry system 512 coupled to inductive coil 514,communication unit 516, user interface 518, input and output circuitry(I/O) 520, and power supply 522.

Programmable controller 510 is electrically coupled to, and configuredto control, the internal functional components of external monitoringcomponent 500. Controller 510 may comprise one or more commerciallyavailable microcontroller units that may include a programmablemicroprocessor, volatile memory, nonvolatile memory such as EEPROM forstoring programming, and nonvolatile storage, e.g., Flash memory, forstoring firmware and a log of system operational parameters and patientdata. The memory of controller 510 stores program instructions that,when executed by the processor of controller 510, cause the processorand the functional components of external monitoring component 500 toprovide the functionality ascribed to them herein. Controller 510 isconfigured to be programmable such that programming data is stored inthe memory of controller 510 and may be adjusted using monitoring system400. As will be readily understood to one skilled in the art, while FIG.5 is illustrated to show one programmable controller, multipleprogrammable controllers may be utilized. Controller 510 may storeprogram routines in its memory. For example, controller 510 may store aroutine configured to periodically determine whether sensed parameterswere received from implantable component 200 by a predetermined timelimit and, if not, send an alert to the user and/or clinician.

Controller 510 is coupled to communications circuitry includingtelemetry system 512, which is electrically coupled to coil 514, thatpermits transmission of commands, and optionally power, to sensors 222,224 within implantable component 200 and receipt of signals indicativeof parameters sensed by sensors 222, 224. For example, in an embodimentwhere sensor 222 is a pressure sensor, controller 510 may cause,responsive to user input at user interface 518, telemetry system 512 towirelessly power sensor 222 via coil 514 to cause sensor 222 to sensepressure within reservoir 204. Sensor 222 may transmit a pressure signalindicative of the sensed pressure to external monitoring component 500via telemetry system 512 and coil 514 or communication unit 516. Thetechnology for telemetry system 512 and coil 514 is well known to oneskilled in the art and may include a magnet, a short range telemetrysystem, a longer range telemetry system (such as using MICS RF Telemetryavailable from Zarlink Semiconductor of Ottawa, Canada), or technologysimilar to a pacemaker programmer. Alternatively, coil 514 may be usedto transmit power only, and separate radio frequency transmitters may beprovided in communication unit 516 for establishing bidirectional orunidirectional data communication with sensors 222, 224, for example,when sensors 222, 224 comprise RFID technology.

Communication unit 516 is configured to transmit information, such assignals indicative of sensed parameters and the like, to a remotelocation such as a mobile device running mobile application 600 and/or acomputer running monitoring system 400. Communication unit 516 mayinclude circuitry; e.g., WiFi, Bluetooth, and/or cellular chipsets;configured for wireless communication over a network such as theInternet, a local network, or a telephone network using techniques knownin the art. In one embodiment, controller 510 runs a programmed routineto determine if a sensed parameter is above or below a predeterminedthreshold and, if so, sends an alert and/or data to the clinician, e.g.,via monitoring system 400 or a secure website accessible by thepatient's clinician, or to an emergency service to facilitate emergencytreatment.

User interface 518 is configured to receive user input and, optionally,to display information to the user. User interface 350 may includebuttons for receiving user input and a display for displayinginformation to the user, e.g., buttons and display of user interface 504in FIG. 1. As will be readily apparent to one skilled in the art, userinterface 518 is not limited thereto and may use one or more of a touchscreen, a keypad, a microphone, a speaker, a trackball, or the like. Auser may, for example, provide user input by pressing a button to causecontroller 510 to direct telemetry system 512 to transmit a command tobegin sensing and/or power, via coil 514, to a sensor within implantablecomponent 200. Then, one or more signals indicative of the sensedparameters from the sensor may be received and the display of userinterface 518 may display the measured parameter.

Input and output circuitry (I/O) 520 may include ports for datacommunication such as wired communication with a computer/mobile deviceand/or ports for receiving removable memory, e.g., SD card, upon whichprogram instructions or data related to external monitoring component500 use may be stored. In one embodiment, I/O 354 comprises a port, andcorresponding circuitry, for accepting a cables to electrically coupleexternal monitoring component 500 to the mobile device running mobileapplication 600 or to the computer running software-based monitoringsystem 400.

Power supply 522 powers the electrical components of external monitoringcomponent 500, and may comprise a primary cell or battery, a secondary(rechargeable) cell or battery or a combination of both. Alternatively,power supply 522 may be a port to allow external monitoring component500 to be plugged into a conventional wall socket for poweringcomponents. In one embodiment, power supply 522 comprises one or moreports and one or more cables that enable external monitoring component500 to be powered from the mobile device running mobile application 600.

Referring now to FIG. 6, apparatus and method 650 for downloading andusing mobile application 600 on the mobile device are now described. Aswill be apparent to one of ordinary skill in the art, method 200 may beembodied in program instructions stored on the memory of the mobiledevice that, when executed by one or more programmable controllers,cause the mobile device to provide the functionality ascribed to themherein. The program instructions may be software downloaded onto thememory of the mobile device. For example, mobile application 600 may benon-transitory computer readable media.

At 652, mobile application 600 is downloaded onto the mobile device.Mobile application 600 may be a dedicated application or “app” and maybe downloaded from an online store such as iTunes™ (Apple, Inc.,Cupertino, Calif.), the App Store (Apple, Inc.), Google™ Play (Google,Inc., Mountain View, Calif.), the Android™ Marketplace (Google, Inc.),Windows™ Phone Store (Microsoft Corp., Redmond, Wash.), or BlackBerry™World (BlackBerry, Waterloo, Ontario, Canada). Preferably, mobileapplication 600 need only be downloaded once—although updates may bedownloaded—and the remaining portions of method 650 may be repeatedwithout the need to repeat 652.

At 654, one or more signals indicative of sensed parameters are receivedat the mobile device from external monitoring component 500. Forexample, a signal may be received using wireless communication circuitrywithin the mobile device; e.g., WiFi circuitry, Bluetooth circuitry,cellular circuitry or the like; from corresponding communicationcircuitry, e.g., communication unit 516, of external monitoringcomponent 500.

At 656, mobile application 600 runs a programmed routine to determinewhether each sensed parameter is above a predetermined threshold orbelow another predetermined threshold. For example, the programmedroutine may determine whether the pressure sensed using sensor 222 isabove a first predetermined threshold or below a second predeterminedthreshold, may determine whether the humidity sensed using sensor 224 isabove a third predetermined threshold or below a fourth predeterminedthreshold, and/or may determine whether flow rate measured with a thirdsensor within reservoir 204 is above a fifth predetermined threshold orbelow a sixth predetermined threshold, etc. The predetermined thresholdsmay be stored in a lookup table used with mobile application 600 and thethresholds may be adjusted, e.g., by the clinician using monitoringsystem 400.

At 658, if the sensed parameter is not above a predetermined thresholdand not below another predetermined threshold, the sensed parameter isdisplayed on the display of the mobile device. The sensed parameter maybe displayed as a numerical measurement, a wave form, text, a plot, achart, a graph, or the like. Multiple sensed parameters may be displayedat one time and the displayed sensed parameters may be real-timemeasurements. In one embodiment, information indicative of pressurewithin implantable component 200 is displayed based on the sensedpressure signal. Then, sensed parameters may be continuously receivedand 654, 656, and 658 continuously repeated.

At 660, if the sensed parameter is above a predetermined threshold orbelow another predetermined threshold, then an alert is generated. Thealert may be displayed on the display of the mobile device and/or may besent remotely. For example, an alert may be transmitted to theclinician, e.g., for display on the computer running monitoring system400, or may cause the mobile device to call the clinician or anemergency number for immediate patient assistance. Then, sensedparameters may be continuously received and 654, 656, 658, and 660continuously repeated.

Referring now to FIGS. 7-11, exemplary screen shots generated by userinterface block 410 of monitoring system 400 are described for a systemin accordance with the present disclosure. In FIGS. 7-11, variousgraphical user interfaces may be displayed by clicking on tabs 700across the top of the page. As should be understood, tabs 700 may becombined onto a single screen or separated in a user friendly manner.

FIG. 7 shows a graphical user interface 704 of patient/device screen 702that is displayed to a clinician running software-based monitoringsystem 400. Graphical user interface 704 is configured to displaypatient information 706, e.g., patient name and patient ID, andimplantable component information 708, e.g., device serial number.Patient information 706 and implantable component information 708 may beinputted at User Interface block 410 or scanned into the computer usingknown techniques such as bar code/RFID scanning Graphical user interface704 also may display implant information 710, e.g., implantablecomponent 200 implantation date, implantable component 200 activationdate, time since activation, time to recommended replacement, and timeto next patient visit. Implant information 710 may be inputted at UserInterface block 410 and certain implant information 710 may becalculated based on user input. For example, monitoring system 400 mayrun routines to determine time since activation based on the activationdate, time to recommended replacement based on the implantation and/oractivation date, and the time to next patient visit utilizing timingmodules known in the art. Patient information 706, implantable componentinformation 708, and implant information 710 may be saved in the memoryof the computer running monitoring system 400 or at a suitable database.

FIG. 8 shows a graphical user interface 802 of hemodynamics screen 800that is displayed to a clinician running software-based monitoringsystem 400. Graphical user interface 802 is configured to displaypulmonary artery pressure (PAP) information 804, e.g., heart rate (HR),mean pressure (mPAP), systolic pressure (sPAP), and diastolic pressure(dPAP). Graphical user interface 802 further is configured to displaypressure plot 806, e.g., PAP waveform trace. Pressure plot 806illustratively shows pressure versus time during two cardiac cycles. HR,mPAP, sPAP, and dPAP may be calculated using routines programmed inmonitoring system 400 based on parameters sensed by system sensors 340such as pressure within implantable component 200. For example,monitoring system 400 may run routines to determine dPAP using theminimum sensed pressure 808 and to determine sPAP using maximum sensedpressure 810. Graphical user interface 802 may further display themaximum change in pressure over change in time (dp/dt Max) and theAugmentation index. The augmentation index may be calculated using aroutine run by monitoring system 400 to divide late systolic pressure812 by peak systolic pressure 810. Graphical user interface 802 also maydisplay pulmonary artery compliance 814. Monitoring system 400 isconfigured to run a routine to calculate pulmonary artery compliancebased on cardiac output inputted at User Interface block 410. Cardiacoutput may be determined using echo technology.

FIG. 9 shows a graphical user interface 902 of gas added screen 900 thatis displayed to a clinician running software-based monitoring system400. Graphical user interface 902 is configured to display fluidinformation 904, e.g., gas added, gas lost to diffusion, gas volumeadded due to pressure change. Graphical user interface 902 further isconfigured to display diffusion information 906, e.g., gas diffusionrate, status alert. Fluid information 904 and diffusion rate 906 may beinputted at User Interface block 410 or may be calculated using routinesprogrammed in monitoring system 400 based on parameters sensed by systemsensors 340 such as pressure, volume, and/or flow rate withinimplantable component 200. If the gas diffusion rate is above apredetermined threshold, graphical user interface 902 may display analert/alarm.

FIG. 10 shows a graphical user interface 1002 of moisture managementscreen 1000 that is displayed to a clinician running software-basedmonitoring system 400. Graphical user interface 1002 is configured todisplay moisture information 1004, e.g., humidity, temperature, liquidremoved, liquid penetration level, liquid penetration diffusion rate.Moisture information 1004 may be inputted at User Interface block 410 ormay be calculated using routines programmed in monitoring system 400based on parameters sensed by system sensors 340 such as humidity andtemperature within implantable component 200 and volume of injectedfluid from and volume of extracted fluid to external clinical controllercomponent 300. If the liquid penetration level is above a predeterminedthreshold, graphical user interface 902 may display an alert/alarm. Inaddition, if the liquid penetration diffusion rate is above apredetermined threshold, graphical user interface 902 may display analert/alarm.

FIG. 11 shows a graphical user interface 1102 of device function screen1100 that is displayed to a clinician running software-based monitoringsystem 400. Graphical user interface 1102 may display pulmonary arterycompliance 1104. Monitoring system 400 is configured to run a routine tocalculate pulmonary artery compliance based on cardiac output inputtedat User Interface block 410. Cardiac output may be determined using echotechnology. Graphical user interface 1102 also is configured to displayPAC information 904, e.g., PAC added, native PAC. PAC information 1106may be inputted at User Interface block 410 or may be calculated usingroutines programmed in monitoring system 400. For example, native PACmay be inputted at User Interface block 410 before implantable component200 is implanted or while deactivated and saved within memory. PAC addedmay be calculated using a routine to subtract native PAC from PACcalculated at 1104. Graphical user interface 1102 further is configuredto display compliant member 202 volume information 1108, e.g., ballooncollapse percent, inflated volume, deflated volume, and balloon totalvolume. Volume information 1108 may be inputted at User Interface block410 or may be calculated using routines programmed in monitoring system400 based on parameters sensed by system sensors 340 such as pressure,volume, and/or flow rate within implantable component 200.

As will be readily understood by one of ordinary skill in the art, thedisplayed information may be displayed in suitable units of measurement.In addition, a user may enter data into the user interface usingsuitable mechanisms known in the art, such as, entering numbers,letters, and/or symbols via a keyboard or touch screen, mouse, touchpad,selection from a drop-down menu, voice commands, or the like.

EXAMPLE 1

Implantable components constructed in accordance with the presentdisclosure were implanted in calves suffering from altitude-induced PHsuch that the balloon was positioned in the main pulmonary artery justdownstream of the pulmonary valve and inflated and deflated with eachcardiac cycle. Altitude-induced PH cattle are widely considered to bethe best large animal chronic PH model available. Calves living ataltitude on high mountain ranches routinely develop severehypoxia-induced PH and a significant fraction of them develop BrisketDisease (uncompensated right heart failure). Right heart catheterizationand histological examination of these animals have shown hemodynamicperformance and small vessel remodeling similar to severe PH in humans.FIG. 12 is a plot illustrating pressure versus time for one calf in thestudy wherein pressure line 1200, showing pressure when the implantablecomponent is activated, is superimposed over pressure line 1202, showingpressure when the implantable component is deactivated. As may beobserved, activation of the implantable component increases diastolicpressure and decreases peak systolic pressure.

EXAMPLE 2

FIG. 13 is a plot illustrating pressure versus time using a benchtopmodel designed to approximate the dimensions and hemodynamic parameterson the right side of the heart and the pulmonary vasculature. In FIG.13, pressure line 1300 shows pressure when the implantable component isactivated while pressure line 1302 (superimposed over pressure line1300) shows pressure when the implantable component is deactivated. Inthis example, a reduction of 17% in peak arterial pressure was achievedupon implantable component activation with a 0.9 ml/mmHg increase incompliance. As may be observed, activation of the implantable componentincreases diastolic pressures and decreases systolic pressures.

While various illustrative embodiments of the invention are describedabove, it will be apparent to one skilled in the art that variouschanges and modifications may be made therein without departing from theinvention. The appended claims are intended to cover all such changesand modifications that fall within the true scope of the invention.

What is claimed:
 1. A system for treating pulmonary hypertension, thesystem comprising: a pulmonary artery anchor (PA anchor) adapted to beimplanted within a pulmonary artery; and an implantable componentcomprising a compliant member coupled to a reservoir via a conduit, thecompliant member adapted to be implanted within the pulmonary artery andthe reservoir adapted to be implanted subcutaneously, the implantablecomponent further comprising an implantable component anchor, whereinthe PA anchor is adapted to be implanted prior to deployment of theimplantable component anchor and the implantable component anchor isconfigured to be coupled to the PA anchor.
 2. The system of claim 1,wherein the PA anchor comprises first and second protrusions and agroove between the first and second protrusions.
 3. The system of claim2, wherein the implantable component anchor is configured to be deployedwithin the groove such that the first and second protrusions maintainthe implantable component anchor within the groove.
 4. The system ofclaim 2, wherein the first and second protrusions have an annular shape.5. The system of claim 1, wherein the PA anchor is configured to expandfrom a contracted state to an expanded state.
 6. The system of claim 5,wherein the PA anchor is configured to be compressed within a sheath inthe contracted state and to expand to the expanded state when exposedfrom the sheath.
 7. The system of claim 5, wherein the PA anchor isconfigured to expand to the expanded state responsive to expansion ofthe compliant member.
 8. The system of claim 1, wherein the implantablecomponent anchor comprises one or more arms coupled to the conduit andconfigured to expand to couple the implantable component to the PAanchor.
 9. The system of claim 8, wherein the one or more arms arewire-like.
 10. The system of claim 1, wherein the compliant member isconfigured to be detachable from the PA anchor in vivo such that thecompliant member is replaceable while the PA anchor remains implanted.11. The system of claim 1, wherein the implantable component anchor isconfigured to be delivered in a contracted state within a sheath andconfigured to expand when exposed from the sheath to couple to the PAanchor.
 12. The system of claim 8, wherein the one or more arms areconfigured to radially expand when the conduit is rotated in a firstdirection and to radially contract when the conduit is rotated in asecond direction, opposite the first direction.
 13. The system of claim3, wherein the first and second protrusions and the implantablecomponent anchor are radiopaque to permit visualization during delivery.14. A method for implanting a system for treating pulmonaryhypertension, the method comprising: implanting a pulmonary arteryanchor (PA anchor) within a pulmonary artery; after implanting the PAanchor, delivering a compliant member and an implantable componentanchor of an implantable component to the pulmonary artery, theimplantable component further comprising a reservoir adapted to becoupled to the compliant member via a conduit; coupling the implantablecomponent anchor to the PA anchor such that the compliant member isdisposed within the pulmonary artery; and subcutaneously implanting thereservoir.
 15. The method of claim 14, wherein the PA anchor comprisesfirst and second protrusions and a groove between the first and secondprotrusions, and wherein coupling the implantable component anchor tothe PA anchor comprises deploying the implantable component anchorwithin the groove such that the first and second protrusions maintainthe implantable component anchor within the groove.
 16. The method ofclaim 15, wherein the first and second protrusions and the implantablecomponent anchor are radiopaque, and wherein coupling the implantablecomponent anchor to the PA anchor further comprises visualizing thefirst and second protrusions and the implantable component anchor. 17.The method of claim 14, wherein implanting the PA anchor comprisesdelivering the PA anchor within a sheath in a contracted state andexpanding the PA anchor to an expanded state when exposed from thesheath in the pulmonary artery.
 18. The method of claim 14, whereindelivering the compliant member and the implantable component anchorcomprises delivering the implantable component anchor in a contractedstate within a sheath, and wherein coupling the implantable componentanchor to the PA anchor comprises expanding the implantable componentanchor to an expanded state when exposed from the sheath.
 19. The methodof claim 14, wherein coupling the implantable component anchor to the PAanchor comprises rotating the conduit in a first direction to radiallyexpand the implantable component anchor within the PA anchor.
 20. Themethod of claim 19, further comprising rotating the conduit in a seconddirection, opposite the first direction, to radially contract theimplantable component anchor; and removing the compliant member and theconduit from the pulmonary artery.